Sandoz proposed biosimilar rituximab accepted for review by the FDA

Rituximab is indicated to treat blood cancers and immunological diseases such as rheumatoid arthritis. Sandoz believes the comprehensive data package submitted to the FDA for review confirms that our biosimilar rituximab matches the reference medicine in terms of safety, efficacy and quality The global leader in biosimilars, Sandoz has five biosimilars approved worldwide including biosimilar rituximab, which was approved in Europe* in June 2017 Holzkirchen, September 12, 2017 - Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan ^** (rituximab). Rituxan ^** is used to treat blood cancers including non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis. "The cost of treating cancer in the US is a major concern for many patients and their families as well as for the healthcare system " said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals. "With the FDA acceptance of our regulatory submission for proposed biosimilar rituximab, we plan to deliver patients a high-quality Sandoz biosimilar that, following approval, could help drive healthcare savings and increase competition, while freeing up resources for and supporting patient access in other areas of cancer care including innovative therapies." The BLA consists of a comprehensive data package that includes analytical, preclinical and clinical data.